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rights of the third party violating.
Refer to this manual before the product is used. The manual includes operating procedures which
must be performed with cautiously, operations that may result in non-normal working conditions
and the dangers which may damage equipment or cause bodily harm. Our company is not
responsible for the security, reliability and function of the equipments in case that the dangers,
damages and non-normal phenomenon mentioned in this manual happen. Free repairs for these
malfunctions will not be provided by our company.
Our company has the rights to replace any content in this manual without notice.
Manufacturer Responsibility:
Our company responsible for the security, reliability and function of the equipments when to
following conditions are adhered to:
Installation, adjustments, mending and repairs must be performed by individuals authorized
by our company;
Necessary electrical equipment and the working environment must be in accordance with the
national standards, professional standards and the requirements listed in this manual;
Equipment must be used as instructed in the operating instructions.
CAUTION: This equipment is not for family use.
CAUTION: Malfunctioning equipment may become invalid and cause bodily injury if a set
of effective and approving repairing proposals cannot be submitted by the
institution which is responsible for using this equipment.
The paid theoretical framework diagram will be supplied according to customer requirements by
our company, plus calibrating method and other information to help the customer, under the
assistance of qualified technicians, repair the equipment parts where can be done by customer
himself based on the stipulation by our company.
Warranty:
Manufacturing techniques and materials:
For a period of one year from the date of original delivery, the components and assemblies of this
product is warranted to be free from defects manufacturing techniques and materials, provided
that the same is properly operated under the conditions of normal use and regular maintenance.
The warranty period for other parts is three months. Expendable parts are not included. Our
obligation under the above warranties is limited to repairing free of charge.
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User Manual
Free Obligations:
Our obligation under the above warranties does not include the freight and other fees;
Our company is not responsible for any direct, indirect or final product broken and delay which
result from improper use, alteration by using the assemblies unratified and maintenance by
anyone other than our company;
This warranty does not apply to the followings:
Improper use
Machines without maintenance or machines broken
The label of our original serial number or mark is removed or replaced
Other manufacturers’ product
Return
Follow the steps below in case that the product needs to be returned to our company:
1. Obtain the rights of return
Contact our customer service by informing them the number and type of the product. The number
is marked on the surface of the product. Return is unacceptable if the number cannot be identified.
Enclose a statement of the number, type and the reason of return as well.
2. Transportation charges
Transportation and insurance charges must be prepaid by the user for transporting the product to
our company for repairing. (Customers charges is added with regard to the products sold to
non-Chinese mainland users)
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Contents
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User Manual
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Contents
v
1 Introduction
1.1 Intended Use
The ADSIII Anesthesia machine is intended for general anesthesia use. The ADSIII Anesthesia
machine will delivery operator set concentrations of oxygen and anesthesia gases as well as
deliver controlled breaths to the patient with either a constant or a deceleration flow pattern. ADSIII
Anesthesia machine is also intended to allow for the provision of manual ventilation.
Intended operator:
The ADSIII Anesthesia machine is intended for use by Healthcare professionals who are trained in
the administration of anesthesia.
Intended Patient Populations:
The Anesthesia machine is intended for use on the neonatal to adult patient populations in all
ventilation modes.
Intended Use Environment:
The Anesthesia machine is intended to be used in the environments where anesthesia is to be
administered by Healthcare professionals trained in administering anesthesia.
It is not intended for transport use in ambulances or helicopters.
1.1.2 Contraindication
ADSIII is not to be used with patients who have pneumothorax.
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1.2 Symbols
Warnings and Cautions indicate all the possible dangers in case of violation of the
stipulations in this manual. Refer to and follow them.
WARNING indicates potential hazards to operators or patients
CAUTION indicates potential damage to equipment
Instead of illustrations, other symbols may also be utilized. Not all of them may necessarily appear
in the equipment and manual. The symbols include:
Attention, consult
DC: Direct current
accompanying document
Lock Unlock
1—2
1. Introduction
Recyclable Battery
Variability, rotational
Bell cancel adjustment (increase
counter-clockwise)
Non-ionizing
Bell
electromagnetic radiation
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2 System Components
2.1 Anesthetic System
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2. System Components
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2. System Components
CAUTION: The breathing system used together with the anesthetic gas supply
system shall be in accordance with ISO 8835-2.
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2.5 Vaporizer
CAUTION: The Vaporizer used with the anesthetic system shall comply with ISO
8835-4.
Two vaporizers with Selectatec interface can be installed in this system, but only one vaporizer
can be opened at one time.
More detailed information about vaporizer, please refer to the instruction for use of the vaporizer
used in this anesthetic system.
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3 UI
CAUTION: Anesthetic ventilator used in anesthetic system shall comply with ISO
8835-5.
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3.1.1 Keys
As the system is under STANDBY mode, press
AUTO/MANUAL key to shift to MANUALmode,
or turn the navigation knob to change to
MANUAL mode; the system will shift to IPPV
Manual/Auto Key mode by pressing AUTO/MANUAL key again.
Under other ventilation modes, press
AUTO/MANUAL key to shift to MANUAL mode,
press the key again to return to the previous
ventilation mode.
3.1.2 Indicator
3—2
3. UI
Operating method:
Move the cursor to the item where the operation is wanted
Pull down menu or dialogue box may appear on the screen, or the original menu is
replaced by the new menu.
Save setup.
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The bell icon shall be displayed when an alarm is present. When it appears, the color of alarm bell
shall be white. Pressing the alarm mute key shall place an “X” dashed line on the alarm bell for
120 seconds. Displayed below the bell icon shall be a countdown timer which shall display
remaining silence time.
Technical Alarm and Functional Alarm shall be displayed in the alarm message area. High Priority
alarms shall be colored red. Mid and low priority alarms shall be colored yellow. Up to 2 alarm
messages shall be displayed on the screen. More details refer to Chapter 9.
3.2.1.3 Date
The display mode of Date has three types: MM/DD/YY, DD/MM/YY or YY/MM/DD.
3.2.1.4 Time
Located the left of Ventilation Mode tile, there are two icons: AC and Battery.
The display status of Battery includes: Full, Charging and Capacity left.
The display status of AC includes: AC available/ready and AC failure.
AC power up: (1) The Battery icon shows 100% capacity as solid when fully charged. (2) if in
charging, the Battery icon shows animated capacity.
AC power down: (1) The Battery icon shows the current capacity. (2) The Battery can supply
power for the machine about 15 minutes when low battery alarm occurs.
The patient type shall be displayed as Adult or Child. Highlighting (black text on white background)
the Patient type tile and pressing the navigator knob shall toggle the patient type between Adult
and Child. Changing patient type shall be possible in standby mode only.
The default patient type on power-up shall be ADULT.
Pressing the navigator knob when the Mode tile is highlighted shall display the current ventilation
mode in white text on a black background and the “MODE” label shall remain displayed in black
text on white background. Rotating the navigator knob clockwise shall allow the user to scroll
through the ventilation mode selections; STANDBY, IPPV, PCV, SIMV and PS. Rotating the
navigator knob counterclockwise shall scroll through the settings in the reverse order.
STANDBY shall be the default mode on initial power up.
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3. UI
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3—6
3. UI
3.4 Menu
3.4.1 Operating Guide
Calibrate or carry out other process, explanation will be displayed on the screen.
Step 1
Press MENU key, then display a “Menu” window on the screen.
The following example is given to illustrate how to operate the detailed settings.
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3. UI
NOTE: The parameter settings for MV, Freq., FiO2 and Alarm Volume are the same as
the method for PAW setting.
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Step 1
There are two forms for PRESSURE DISPLAY: Plat and Pmean.Press the knob to select the
target pressure display form.
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3. UI
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3. UI
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3. UI
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3. UI
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3. UI
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4 Operating Guide
4.1 Startup
Step 1 Connect Mains Supply
Plug the power cord into AC power outlet, The AC indicator on the UI will be bright.
Step 2 Turn on Power Switch
Turn the Power Switch to “ON”, the UI shall be powered on and perform System Self Test.
NOTES: The color of a hand icon is white, which is in consistent with the color of
the operating procedure being performed.
NOTES: If system leak test fails, the mechanical ventilation modes, such as IPPV,
SIMV, PCV and PS will be retained.
NOTES: As CO2 waveform setting will be saved, the default status is the one that
is setup in the previous operation.
The display enters startup interface when UI powered on, and then the LOGO interface will be
shown as follows, See Figure 4-1.
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4—2
4. Operating Guide
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4. Operating Guide
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4. Operating Guide
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4. Operating Guide
Step 1
Turn the knob; make cursor point to the current ventilation mode.
Step 2
Press the knob to make sure the grounding changed.
Step 3
Turn the knob to select ventilation mode required.
Step 4
Press the knob to save the setup.
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WARNING: Before getting started, make sure to set the patient circuit installing and
controlling correctly.
The following procedures assume that the system is in on position and
manual reservoir gas ventilating mode.
WARNING: Before getting started, make sure to set the patient circuit installing and
controlling correctly.
NOTES: As the system is under STANDBY mode, press AUTO/MANUAL key to
shift to MANUALmode, or turn the navigation knob to change to
MANUAL mode; the system will shift to IPPV mode by pressing
AUTO/MANUAL key again. Under other ventilation modes, press
AUTO/MANUAL key to shift to MANUAL mode, press the key again to
return to the previous ventilation mode.
Step 1
Make sure the control settings coincide with the clinical settings, and check that the current alarm
preset is appropriate prior to use on each patient.
Step 2
Select auto ventilation. Setting steps refer to section 4.1.6.
Step 3
If necessary, push the O2 flush button to inflate the bellows.
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4. Operating Guide
Step 1
Before stopping the auto ventilation, make sure the setting of manual circuit is complete, and the
setting of APL valve is correct.
APL valve is used to adjust the pressure limit of the breathing system during the manual ventilation
period.
Step 2
Set ventilation mode to Manual mode, or press key directly. So you can use the
resovior bag to perform manual ventilation, if necessary, push the O2 flush button to inflate the
bellows.
4.4 Shutdown
Turn off gas supply firstly, then set ventilation mode to Standy mode after the gas within the
system exhausted.
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4.5 Waveforms
4.5.1 Paw-t waveform
Y-Axis: airway pressure; X-Axis: time. More details refer to section 10.8.7.
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4. Operating Guide
4—13
5 Preuse Checkout
5.1 Preuse Checkout Procedure
Test interval Preoperative Checkout should be done in the following situation:
Before use of the first patient each day.
Before use of each patient.
After repair or maintenance.
Test schedule is given in the table below:
Before use of the first patient each day Before use of each patient
System check: Breathing System test:
Power failure alarm test: Ventilator test:
Gas pipeline and gas cylinder test:
Flow control test:
Vaporizer installation and test
Alarm test:
Breathing system test:
Ventilator test:
WARNING: Do not use this system before the operation and maintenance manual
are read and understood.
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User Manual
WARNING: make sure the breathing circuit is connected correctly and in good
condition.
Make sure:
1 Equipment is in good condition.
5 The connection and pressure of pipeline gas supply system are correct.
6 The connected cylinder valve should be closed if there are backup cylinders.
8. The device for airway maintenance, organ cannula are ready and in good condition.
10. Make sure the truckles are tight and locked and free of motion.
11. Connect the power cord to the AC power outlet. The power indicator light will light up
when power is connected.
If failure, that means no electric power supplying. Exchange other sockets, close breaker,
or replace power cord.
5—2
5. Preuse Checkout
CAUTION: A user must confirm that gas supply is connected correctly; there is no
any disconnection, leakage, faulty connection in gas circuits and
pressure indicates correctly. Stop using and check gas connections if
abnormal.
Make sure all the pressure gauges are reset to zero except the O2 pressure gauge.
Switch off O2 supply.
Make sure the O2 pressure gauge is reset to zero. The low O2 supply alarm should
be on when pressure drops.
4 Close flowmeters.
8 Begin to record the pressures after one minute. If O2 pressure drops to 5000kPa, it
means there is a leakage:
If leakage exists, according to direction of section 5.5, replace a new sheet gasket,
and then tighten T handle.
Perform this step again. If leakage exists all the same, do not use this system.
9 Step 5 ~ 7 should be repeated for all the cylinders. N2O pressure drop in one minute
should not exceed 700kPa.
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CAUTION: Do not leave the cylinder valves open during pipeline gas supply period;
otherwise, cylinder gas supply will be used up and lead to insufficient
supply in case of pipeline malfunction.
WARNING: The monitoring system cannot be replaced by link system. The fresh
gas containing enough oxygen may not avoid the existence of low
oxygen mixture in the breathing circuit.
WARNING: If N2O exists, it will pass through the system during the test, which
should be securely collected and removed.
WARNING: Patients may be injured by improper gas mixture. The link system
should not be used if a proper ratio of O2 and N2O is not possible.
WARNING: The following procedures can test whether the link system has serious
malfunction; however, it cannot determine whether the calibration is
correct.
CAUTION: The gas flow control valve should be adjusted slowly. Do not turn it
hard when the reading of the flowmeter goes beyond the maximum or
minimum flow rate; otherwise, the control valve can be damaged and
the control will not work.
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5. Preuse Checkout
Step 6 and step 7 are only applicable for the N2O system test.
Turn clockwise the N2O and O2 flow control till the end.
Set N2O flow to O2 flow must be higher than the minimum flow
(liters per minute): (liters per minute):
1.5 0.5
3 1
6 2
9 3
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7. This step tests the function of the Link System when flow is reduced, you should:
Set N2O flow to O2 flow must be higher than the minimum flow
(liters per minute): (liters per minute):
6.0 2.0
3.0 1.0
0.6 0.2
8. Adjust full flow of all the gas to ensure that the flowmeter float must move smoothly.
9. Shut off the oxygen supply either by closing the oxygen cylinder valve, or by disconnecting
the oxygen pipeline supply.
10. Make sure:
Disconnect the flow of nitrous oxide and oxygen to be sure that the oxygen flow will be
the last to stop.
Air flow remains.
If the oxygen is the driving gas of the ventilator, the oxygen-supply failure alarm must
continuously sound.
11. Turn all flow control valves completely clockwise to the close.
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5. Preuse Checkout
WARNING: The monitoring system cannot be replaced by link system. The fresh
gas containing enough oxygen may not avoid the existence of low
oxygen mixture in the breathing circuit.
If N2O exists, it will pass through the system during the test, which
should be securely collected and removed according to safe and
eligible methods.
Patients may be injured by improper gas mixture. The link system
should not be used if a proper ratio of O2 and N2O is not possible.
1. Connect the pipeline gas supplies, or slowly open the cylinder valve.
4. Do not use this system if the battery is not fully charged or other ventilator failure alarms occur.
5. Make sure:
Step 6 and step 7 are only applicable for the N2O system test.
Turn clockwise the N2O and O2 flow control till the end.
Turn counterclockwise the N2O flow control slowly.
Make sure that the O2 flow is increasing. The concentration of the oxygen tested must ≥
25% during the complete process.
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8 Adjust all of the gas full flow to ensure that the flowmeter floats must move smoothly.
9 Shut off the O2 supply either by closing the O2 cylinder valve, or by disconnecting the O2
pipeline supply.
10 Make sure:
Disconnect the flow of nitrous oxide and oxygen to be sure that the oxygen flow will be
the last to stop.
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5. Preuse Checkout
WARNING: Do not take the vaporizer away from the bypass valve with its locking
lever locked.
Do not use more than one vaporizer at the same time in this system.
Install vaporizers in accordance with the following steps:
1. The vaporizer must be disassembled and reinstalled if its top is not horizontal.
2. Set the locking lever of the vaporizer so that it is locked.
3. Try to lift the vaporizer directly upwards so as to separate itself from the bypass valve, but do
not pull the vaporizer forwards. Be careful not to rotate it on the bypass valve.
4. As the vaporizer is taken away from the bypass valve, reinstall the vaporizer and then follow
step 1 to step 3. Do not use this system if you cannot put return the vaporizer to a horizontal
position on the bypass valve.
If more than one vaporizer can be opened at the same time, disassemble and reinstall
them, then perform step 1 to step 5.
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4 Set ventilation mode to Manual ventilation, and then set to IPPV control again. Make sure:
Auto ventilation start.
Adjust upper limit of O2 concentration to 100%, and conform that the alarm eliminates.
Let O2 sensor pass pure O2 for 2 minutes, and conform that O2 concentration measured
is about 100%.
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5. Preuse Checkout
Adjust lower limit of MV to 16L/min, and conform that “Low Minute Volume!!” alarm
occurs.
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WARNING: Objects in the breathing system can interrupt or disrupt the delivery of
breathing system gas, resulting in possible patient death or injury:
Do not use any testing plug small enough to slip completely into the
breathing system.
WARNING: Be sure that there is no any testing plug or foreign objects in the
Breathing System.
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5. Preuse Checkout
10 Set the ventilator control and alarm limits to the proper clinical level.
11 Turn off mains supply and close all valves of gas cylinders if not to use the system.
12 Ensure that the things in the following table should be prepared completely.
13 System preparation:
WARNING: Flush the anesthesia machine for at least one minute by using O2 with
5L/min flow speed to remove unnecessary mixed gas and objects in the
system before connecting the equipment to the patient end.
5—13
6 Installation and Connection
CAUTION: O2 monitoring must be used on this equipment. For the related
stipulations, refer to local standards.
CAUTION: According to IEC 60601-2-13 / ISO 8835-1, this equipment must use
expiratory volume monitoring, O2 monitoring (in accordance with EN
12342 or ISO 21647) and CO2 monitoring (in accordance with EN 864 or
ISO 21647).
WARNING: Be sure the gas pipeline supply hoses and the breathing circuit
components are non-poisonous, do not cause patient allergy, and do
not create dangerous by-product through reaction with the anesthesia
gas or the anesthetic.
WARNING: To prevent generating wrong data and malfunction, please use the
cables, hoses, and tubes from our company.
CAUTION: This system can be operated correctly under IEC 60601-1-2 interference.
Higher-level interference may cause alarm and result in auto ventilation
suspension.
CAUTION: To avoid equipment false alarm caused by high strength electric field:
Put the electricity surgical conducting wire far from the place where the
breathing system and the O2 sensor are put on.
Do not put the electricity surgical conducting wire on any parts of the
anesthetic system.
CAUTION: To protect the patient, as the electricity surgical equipment is being
used:
Monitor and ensure that all the life supporting and monitoring
equipment are operated correctly.
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6.1 Installation
Step 1
Unpack the package, take out the main frame and lock its castors so it cannot move freely.
Step 2
Connect the arm to its mounting tracks, then
tighten the screws.
Step 3
When installing, hold the top plate of the
Breathing System with both hands, connect the
position fixing hole to the limb post, sit it on the
limb post.
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6. Installation and Connection
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User Manual
3. Fill the absorber with fresh absorbent after dryness. Wipe soda lime fell on the edge of
absorber, and then install it back. Make sure the airtightness is well, and that no leakage
and spillage.
6—4
6. Installation and Connection
CAUTION: CO2 monitor (in accordance with ISO 9918) should be connected at
L-piece of patient end.
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6. Installation and Connection
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6.4.1 AC Inlet
AC Power: 100~240VAC, 50/60Hz; 8A Max.
Fuse: 250V10A, Φ5X20(F)
Power cable is fixed on the mainframe.
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6. Installation and Connection
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6. Installation and Connection
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CAUTION: Do not turn the cylinder valve on when the pipeline gas supply is being
used. The gas supply of the cylinder may be used out in case of pipeline
failure so that the backup supply may be insufficient.
1 Turn the handle T of the cylinder valve clockwise until it is tight. Close the valve of the cylinder
to be changed.
4 Keep the cylinder inlet away from all the objects which could be damaged by the release of
high pressure gas.
5 To clear the cylinder valve of any debris, use the cylinder wrench to briefly open, then close
the cylinder.
6 Install the cylinder.
Align index pin with the basic hole of the gas cylinder.
Close flowmeter.
If the pressure of the N2O cylinder drops more than 690 KPa after one minute, the high
pressure circuit has an unacceptable leak.
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6. Installation and Connection
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6. Installation and Connection
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CAUTION: being in a condensing atmosphere,the unit shall be stored for more than
24h in an environment equivalent to the operating humidity.
Data output
Fi and ET Fi and ET are displayed after one breath and
have a continually updated breath average.
IRMA CO2:CO2
IRMA AX+: CO2,N2O,primary and secondary
agents(HAL,ISO,ENF,SEV,DES)
Automatic agent IRMA AX+:Pramary and secondary agent.
identification
Gas analyzer
Calibration Zeroing recommended when changing Airway
adapter
Warm-up time Concentrations are reported and the automatic
agent identification is running within 10 seconds.
Full accuracy within 1minute.
Rise time(@10l/min) CO2≦90s
N2O≦300s
HAL,ISO,ENF,SEV,DES≦300s
Agent identification <20 seconds.(Typically<10 seconds)
time
Total system response <1 second
time
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6. Installation and Connection
1. Connect the IRMA connector(RS-232 serial interface) with the COMA below the UI.
2. Snap the IRMA sensor head on top of the IRMA airway adapter.Ii will click into place when
properly seated.
3. A green LED indicates that the IRMA probe is ready for use.
4. Connect IRMA/airway adapter 15mm male connector to the breathing circuit Y-piece.
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5. Connect the IRMA/airway adapter 15mm female connector to the patient’s endotracheal tube.
When connecting IRMA probe to an infant patient circuit it is important to avoid a direct contact
between the IRMA probe and the patient’s body.
If ,for whatever the reason,the IRMA probe is in direct contact with any parts of the infant’s body an
insulation material shall be placed between the IRMA probe and the body.
WARNING: The IRMA probe is not intended to be in long term skin contact.
Always verigy gas readings and waveforms on the monitor before connecting the airway adapter
to the patient circuit.
Perform the tightness check of the patient circuit with the IRMA probe snapped on the IRMA
airway adapter.
In order to secure high precision of the IRMA probe measurements the following zeroing
recommendations should be followed.
Zeroing is performed by snapping a new IRMA airway adapter onto the IRMA probe,without
connecting the airway adapter to the patient circuit,and then using the host instrument to transmit
a Zero reference command to the IRMA probe.
Special care should be taken to avoid breathing near the airway adapter before or during the
Zeroing procedure.The presence of ambient air(21%O2 and 0%CO2) in the IRMA airway adapter is
of crucial importance for a successful Zeroing.If a “ZERO-REQ” alarm should appear directly after
a Zeroing procedure,the procedure has to be repeated.
Always perform a pre-use check after Zeroing the probe.
IRMA CO2 probes:
Zeroing needs to be performed ONLY when an offset in gas values is observed, or when an
unspecified accuracy message is displayed.
Allow 10 seconds for warm up of the IRMA CO2 probes after power on before proceeding with the
Zeroing Procedure.
Allow the IRMA probe to warm up for at least 10 seconds after changing the IRMA airway adapter
before transmitting the Zero reference command.
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6. Installation and Connection
IRMA AX+probes:
Zeroing should be performed every time the IRMA airway adapter is replaced,or whenever an
offset in gas values or an unspecified gas accuracy messages is diaplayed.
Allow 1 minute for warm up of the IRMA AX+ probes after power on and after changing the IRMA
airway adapter before proceeding with the Zeroing Procedure.The green LED on the probe will be
blinking for approximately 5 seconds while zeroing is in progress.
6.7.5 Alarms
Include a description of the status LED situated on the IRMA probe:
Steady green light System OK
Blinking green light(IRMA AX+) Zeroing in progress
Steady blue light Anesthetic agent present
Steady red light Sensor error
Blinking red light Check adapter
6.7.6 Cleaning
The IRMA probe can be cleaned using a cloth moistened with athanol or isopropyl alcohol.
CAUTION: The IRMA oxygen sensor cell and IRMA airway adapters are non-sterile
devices.Do not autoclave the devices as this will damage them.
CAUTION: Never sterilize or immerse the IRMA probe in liquid.
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6.7.8 Warnings
Include the following warnings:
The IRMA probe is intended for use by authorized and trained medical personnel only.
The IRMA probe must not be used with flammable anesthetic agents.
Disposable IRMA airway adapters shall not be reused.Used disposable airway adapter
shall be disposed of in accordance with local regulations for medical wasts.
Do not use the IRMA Adult/Pediatric airway adapter with infants as the adapter adds 6ml
dead space to the patient circuit.
Do not use the IRMA Infant/Pediatric airway adapter with adults as this may cause
excessive flow resistance.
Measurements can be affected by mobile and RF communications equipment.It should be
assured that the IRMA probe is used in the electromagnetic environment specified in this
manual.
Do not place the IRMA airway adapter between the endotracheal tube and an elbow as this
may allow patient secretions to block the adapter windows and result in incorrect operation.
To keep secretions and moisture from pooling on the windows or oxygen sensor
port,always position the IRMA probe in a vertical position with the LED pointing upwards.
Do not use the IRMA airway adapter with metered dose inhalers or nebulized medications
as this may affect the light transmission of the airway adapter windows.
Incorrect probe zeroing will result in false gas readings.
Replace the adapter if rainout/condensation occurs inside the airway adapter.
The IRMA probe is not intended to be in long term skin contact.
6.7.9 Cautions
Include the following cautions:
Never sterilize or immerse the IRMA probe in liquid.
Do not apply tension to the probe cable.
Do not operate the IRMA probe outside the specified operating temperature environment.
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6. Installation and Connection
Step 2
Select RETURN to return toSERVICE menu
after confirming the function of CO2 moducle
is activated.
NOTE The gas settings can be available only the function of CO2 is activated.
The method on CO2 module setting is as follows:
Step 1
Return to GAS interface and the default
setting for GAS SENSOR is
DISABLED.Press the knob to disable the
function.
Step 2
The system will return to the main interface
within 5 seconds after enabling the gas
sensor function. The gas monitoring
parameters will be shown at the left side of
the main interface.
Step 3
There are two optionsfor CO2 UNIT
NOTE The default setting for CO2
UNIT is mmHg.
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User Manual
Step 4
Select WAVE DISPLAY and there are two
options FLOW and CO2.
The waveform display on the main interface
correspinds to the waveform display setting.
NOTE The default setting for WAVE
DISPLAY is FLOW.
NOTE The system can
automatically memorize the waveform
display setting,and thewaveform can be
retained to the next system operation.
Step 5
Select SENSOR INFO, press the knob to
enter and the gas module’s version
information will appear on the interface.
6—22
6. Installation and Connection
Step 1
Excess GAS interface and enter
CALIBRATION interface.
Step 2
Press the knob to start CO2 CALIBRATION.
Step 3
Follow the on-screen instructions, wait for 1
minute until the status display turns to green.
NOTE The waiting period for all
IRMA modules is 1 minute.
Step 4
Select NEXT to perform CO2calibrating.The
CO2 calibrating interface will appear.
NOTE The indication light for gas
module is at green and flickering status
during calibration.
CALIBRATON SUCCESSFUL will appear if
the calibration is successful, and select
FINISH to finish calibration.
CALIBRATION FAILED will appear if the
calibration fails, and select REPEAT CAL. to
repeat calibration.
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User Manual
Step 2
Press the knob to start AGENTS
CALIBRATION.
Step 3
Follow the on-screen instructions, wait for 1
minute until the status display turns to green.
6—24
6. Installation and Connection
Step 4
Select NEXT to perform agents calibrating.
The agents calibrating interface will appear.
NOTE The indication light for gas
module is at green and flickering status
during calibration.
6—25
7 Cleaning and Disinfecting
WARNING: Use a cleaning and sterilizing schedule that conforms to your
institution’s sterilization and risk-management policies.
Refer to the material safety data policy of each agent.
Wear safety gloves and safety goggles. The O2 sensor may leak and
burn (by Chlorine Potassium Oxide) if damaged. Do not inhale fumes.
Never use any abrasive agent to clean any of the components (i.e. Steel
wool, silver polish or agent).
WARNING: Talc, zinc stearate, calcium carbonate, or corn starch that has been
used to prevent tackiness could contaminate a patient’s lung or
esophagus, causing injury.
CAUTION: Never immerse the circuit O2 sensor or flow sensor connector in the
liquid.
Do not clean the inner surface of the flow sensor. Clean the outer
surface by using a damp cloth.
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User Manual
7—2
7. Cleaning and Disinfecting
Dismount the cover of the inspiratory and expiratory valves by rotating it counter clockwise, then
clean all parts of them with the gauze soaked with water soluble sterilizing agent, after all parts
cleaned and dried recover it in original integration. Then one must check the leakage and the
movement of the inspiration and expiration valves in accordance with the required regulation and
checking procedure. Please handle all parts with care preventing any damage.
Absorber module
Either vapouring (not more than 50°C) or immersion sterilization can be used in practice, in case
of immersion all sterilized parts must be dried with the high pressure air or oxygen before reuse.
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7—4
7. Cleaning and Disinfecting
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User Manual
WARNING: Never separate the diaphragm and the valve seat in a pressure-relief
valve.
2) To prevent component damage, clean them lightly. Put the recommended nonenzyme mild
agent used for latex and plastic in hot water.
CAUTION: Dry by hanging while fully spread. If moisture is left in the bellows, they
may become tacky.
4) Check the components if they are broken or damp, then perform the assembling and function
test.
Sterilizing
Cleaning and sterilizing must be performed at the same time. Follow instructions for the common
bellows assembly sterilization methods.
Clean the inner and outer parts of the bellows assembly in a soap-and-water solution. Rinse
thoroughly in cold water, and dry with soft cloth. Immerse plastic and latex instruments in 70~80%
ethyl alcohol for half an hour. Take them out using the aseptically transmits pliers, then store in
clean containers. Repeat this step before next use. Components made of metal and glass can be
sterilized with high pressure steam. When the steam pressure is increased by the autoclave, the
rising temperature can concrete the bacterium protein rapidly to kill bacteria. In 1.05 kg/cm2 steam
pressure, the temperature rises to 121°C. All bacteria and most sorus can be killed if this
temperature is maintained for 15~25 minutes.
Open pulmonary TB, pulmonary abscess, pseudomonas, tetanus aeruginosa infection, gas
gangrene or infectious hepatitis is included. Used bellows assembly components must be
completely sterilized according to preliminary and final disposal procedures.
1) Preliminary disposal: Perform in accordance with the isolated disposal stipulation. Collect and
leave all the used bellows assembly components during the operation process in the operating
room. Immerse the bellows assembly components in the 1:1000 benzalkonium bromide or 1~5%
cresol for 30 minutes after finishing the operation.
2) Final disposal: perform the final sterilizing disposal after the bellows assembly components are
processed by the above-mentioned preliminary disposal:
7—6
7. Cleaning and Disinfecting
Scrub the bellows assembly in a soap-and-water solution. Thoroughly rinse in cold water,
and dry;
If conditions permit, suffocating the components directly contacted with patients with
formald or oxirane is preferred, or perform immersing sterilization respectively. For
example: the components used by open pulmonary TB patients must be immersed in 3%
cresol for 30 minutes; the components used by tetanus aeruginosa infection patients
must be immersed in 0.2% potassium permanganate for 30 minutes; the components
used by gas gangrene patients must be immersed in 0.1% chlorhexidine for 30 minutes;
the components used by pulmonary abscess patients must be immersed in 0.1%
benzalkonium bromide for 60 minutes; the components used by pseudomonas patients
must be immersed in 0.1% benzalkonium bromide for 120 minutes;
the components being immersed need to be rinsed by water and dried for next use;
scrub and rinse the components indirectly contacted with patients with 1-3% phenol
solution or soap-and-water solution and water. Irradiate them by using the ultraviolet ray
for 30 minutes if necessary.
WARNING: Do not perform any tests and repairs when the equipment is being
used to avoid patient injury.
Perform the following check every 30 days to be sure that component worn by use and daily
cleaning are replaced in time.
Test by eyes
Separate the bellows assembly and anesthesia machine
Disassemble the bellows assembly
WARNING: Never separate the diaphragm and the valve seat in a pressure-relief
valve
Check each component carefully to check for cracks, distortion, dissolution, inflation and other
physical changes. Replace them if necessary.
Assemble the bellows assembly, and then perform the leak test.
7—7
8 User Maintenance
WARNING: To avoid fire:
Use the lubricant approved for anesthesia or O2 equipments’ use.
Never oil or grease any anesthesia or O2 equipment. In general, oils and
greases oxidize readily, and – the presence of O2 – are highly
flammable.
All the covers or housings for the system use must be made of static
proof material, as static material may cause fire.
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User Manual
When cleaning and Check if any components are broken, and replace or repair them if
installing necessary.
As required Replace new gasket of cylinder gas supply.
Perform flow sensor calibration when flow waveform is unusual.
Replace O2 sensor (one year generally).
Open the drain valve and replace absorbent in the absorber.
8—2
8. User Maintenance
CAUTION: The useful life of the following parts should be considered in normal
environment and operating requirements.
WARNING: Comply with the relevant rules about biohazard when to dispose sensor.
No burning.
Replacement steps:
1 Pull out the connector of sampling cable from O2 sensor.
2 Pull out the O2 sensor from the Breathing system.
3 Replace it with a new one, and connect the sampling cable to O2 sensor.
WARNING: Do not perform the calibration steps when the system connected with
patient.
When to calibrate O2 sensor, ambient pressure must be equal with
monitoring pressure of delivering O2 in the patient circuit.
If operating pressure is not equal with calibrating pressure, the
accuracy of reading may exceed range stated.
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User Manual
8—4
8. User Maintenance
Step 3
Press the knob to perform the calibration.
In the process of calibration, the word “Calibrating” displays on the screen.
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User Manual
If 21% calibration failure, the word “Calibration failed” displays on the window.
If the calibration failure occurs:
Ensure the O2 sensor was connected well and exposed in the air minutes,
repeat these steps to calibrate it again.c
If still failure, check whether the sensor was expired and replace it, then
recalibrate.
8—6
8. User Maintenance
O2 sensor belongs to expendable, so the user should pay attention to period of validity, and use it
in accordance with performance and requirements.
The technical requirements of O2 sensor used in the Anesthesia machine are the following:
Form and definition of interface: RJ11 interface, 4 way FCC-68 teleconnector
Typical input at 21% concentration: 8 to 15 mV
Accuracy in measurement and full scale error: <3% (0 to 100%)
Operating temperature: 0 to 40℃ (32-104℉), tem perature com pensated
Response time: not more than 15 seconds
Useful life: not less than 12 months
Accordable standard: EN 12598 / ISO 7767
Model SV-08A
Manufacturer Sensidyne, Inc.
Response time (second) 7
Useful life (month) 12
Current applied Yes
CAUTION: If the temperature of O2 sensor is lower than dew point of breathing gas,
vapour may coagulate on the surface of sensor, and oxygen
concentration monitored may be lower than practice value.
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User Manual
WARNING: Disconnect from power supply before replacing fuses, otherwise that
can injure operator even death.
WARNING: Replace fuses with only those of the specified type and current rating,
otherwise that can damage the equipment.
8—8
8. User Maintenance
The maintenance of charging should be carried out with interval of 3 months at least if storage of
battery exceeds 3 months.
Stored environment should avoid dampness, high temperature.
If improper maintenance makes battery damage, replace it in time to avoid liquid of battery
corrading the apparatus. Replace the battery, please contact service representatives.
8—9
9 Alarm and Troubleshooting
WARNING: No repair should ever be undertaken or attempted by anyone without
proper qualifications and equipment.
CAUTION: If alarm occurs, protect patient safe firstly, and then go to diagnose fault
or service it necessarily.
Alarm messages displays on the top area of display screen. The distance that the operator can
hear the alarm sound or distinguish the priority of alarm is 4 meters at least. And the distance to
see the alarm message is not less than 1 meter at the front of the machine.
CAUTION: There are two alarm display areas, and the array of alarms is
according to priority from high to low. If the priority is the same, the
alarm messages will be shown in the display area in turn.
CAUTION: When alarm silencing, the alarm bell has dashed
“X” on itself.
Also, the alarm volume can be adjusted by user, and alarm volume option is located in Alarm
submenu. It has 10 segments, the adjusting method refers to 3.4.1.
Alarm signal sound pressure range is between 62dB and 75dB which is tested at a distance of 1m.
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User Manual
CAUTION: Protect patients in operation; repair the fault after the operation finished.
CAUTION: Operation instruction is not included in the alarm message list.
9—2
9. Alarm and Troubleshooting
Message Priority Cause of Alarm Trigger Time Machine Operator Action Repair
Mode
When
Checked
(StartUp /
Run)
Vent/ Manual -- Valve state incorrect. Immediately upon recognizing Startup Call Service Service Rep needed.
Valve Failure failure only Representative
Expiration -- Sensor Data incorrect Startup Call Service
Sensor Failure only Representative
O2 Supply High Drive gas pressure is Immediately upon recognizing StartUp Check pipeline gas Replace O2 cylinder.
Failure lower than 2.9 psi ± 15% failure and supply or
Runtime
Power Fail Low The AC Power Fail Alarm The AC Power Fail alarm shall StartUp Check connection Check mains supply
shall occur when there is occur immediately upon and Check fuses Replace
a failure of the AC Mains. recognizing an AC mains Runtime fuses when blown.
failure.
Low Battery Mid With no AC, battery Immediately upon recognizing Runtime Resume AC power Maintain battery
voltage is lower than 22V. failure immediately; 10 periodically, and
minutes remaining ntil ensure it full charged.
shut down, switch to
Bag mode
O2 Sensor High Check the oxygen sensor If oxygen concentration is less Startup and Use external Replace the oxygen
Failure state by the AD input data than 10%, oxygen sensor will Runtime measuring system sensor.
and judge the Oxygen is be considered failed or
failure or not. disconnected.
This alarm is decided by UI
and displayed in any mode
BDU High If the GUI cannot send or If UI does not receive the Startup and Switch to bag mode, Service Rep needed.
Communication received data from the handshaking instruction from RunTime manually
Failure BDU Unit for more than BDU within 2s, BDU bag(ventilate) patient.
0.5s. communication alarm will be Monitoring still
displayed. This alarm is available.
decided by BDU and
displayed in any mode.
Alarm message for 10s, and
ventilator changes to standby.
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User Manual
Message Priority Cause of Alarm Trigger Time Machine Operator Action Repair
Mode
When
Checked
(StartUp /
Run)
Speaker Failure -- Lack of Main alarm StartUp Ventilator normal Please contact eligible
Feadback only working. Abort or service representative.
ignore by user
Software Version -- BDU, UI, and Keyboard Startup Call Service Service Rep needed.
Fail software versions are only Representative
inconsistent with
released set.
Keyboard Low If UI does not receive the Startup and
Communication handshaking instruction Runtime
Failure from keyboard within 3s,
keyboard communication
alarm will be displayed.
This alarm is decided by
UI and displayed in any
mode.
Pressure Sensor -- Pressure Sensor Data Startup Call Service Service Rep needed.
Failure Incorrect. only Representative
Inspiration -- Inspiration Sensor Data Startup Ventilator failure;
Sensor Failure Incorrect only Switch to bag mode,
manually bag
(ventilate) patient.
Monitoring is not
available.
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9. Alarm and Troubleshooting
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9—6
9. Alarm and Troubleshooting
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9—8
9.3 Troubleshooting
Symptom Possible Cause Recommended Action
Breathing System leak APL valve is on Turn APL valve to off
Canister is not sealed very well Reinstall or remove the natrium
calcareousness grains at the joint
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User Manual
excessive resistance or
vacuum
9—10
10.1
Pressure
adjustable
valve
Patient
Secretion suction
device
O? operated Flowmeter
valve light Flow Flow
N?O adapter adapter
Mass flow
sensor
Cylinder
Electronic
control
Insp. Exp. Pressure
Flowmeter Vaporizer O? sensor gauge
Schematic diagram
Pressure Check
regulator valve Heating
Fresh
gas Fresh Absorber
AIR Solenoid
Flow sensor gas Container
valve
adapter
Pressure
Cylinder switch
Reversing
valve
Driving
Pressure O? flush gas Bellows
Check regulator
Inlet filter valve
280-600KPa Pressure Proportional Safety Throttle
O? regulator solenoid valve
Check
valve
valve APL
Cylinder
Peep Exhaust
Pressure valve
regulator
Ventilator Breathing
O? bag
AGS
Auxiliary Auxiliary
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User Manual
10.2.2 Classification
According to IEC60601-1, ADSIII belongs to the following classifications:
Class I equipment
Type B equipment
General equipment
Mobile equipment
10—2
10 Specifications and Operation Theory
10.3 Input/Output
10.3.1 Electrical
WARNING: Then connection of equipment to the auxiliary mains socket outlets can
increase the patient leakage currents to values exceeding the allowable
limits in the event of a defective protective earth conductor.
10.3.2 Pneumatic
Pipeline supply: O2, Air, N2O
Cylinder supply: O2, N2O
Input pressure at pipeline inlets: 280 to 600kPa
Input pressure at cylinder inlets: 2.5 to 12MPa
Connect to pipeline: DISS-male, DISS-female, NIST (ISO 5359).
All fittings used to connect O2, Air and N2O pipeline gas
supply are all ready.
Connect to cylinder: PISS (pin-indexed safety system)
Reducer: 250kPa
Display pressure: Gauges with color coded
Connect vaporizer: Two Selectatec-type interface vaporizers
Connect to Breathing System Insp. Port connector: Φ22 OD /Φ15 ID
Exp. Port connector: Φ22 OD /Φ15 ID
Breathing System to AGSS: Φ19
Aux. O2 flowmeter: 0-15L/min, barb connector
Aux. Air flowmeter: 0-15L/min, barb connector
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10 Specifications and Operation Theory
Voltage fluctuations/
flicker emissions Complies
IEC 61000-3-3
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User Manual
70% UT 70% UT
(30% dip in UT) (30% dip in UT)
for 25 cycles for 25 cycles
<5% UT <5% UT
(>95% dip in UT) (>95% dip in UT)
for 5 sec for 5 sec
Power frequency 3A/m 3A/m Power frequency magnetic
(50/60Hz) fields
magnetic field Should be at levels
IEC61000-4-8 characteristic of a typical
location in a typical
commercial or hospital
environment.
NOTE UT is the a.c. mains voltage prior to application of the test level.
10—6
10 Specifications and Operation Theory
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption
and reflection from structures, objects and people.
a
The ISM(industrial, scientific and medical) bands between 150kHz and 80MHz are 6.765MHz to 6.795MHz;
13.553 MHz to 14.567 MHz; 26.957 MHz to 27.283 MHz; and 40.66 MHz to 40.70 MHz.
b
The compliance levels in the ISM frequency bands between 150kHz and 80MHz and in the frequency range
80 MHz to 2.5GHz are intended to decrease the likelihood that mobile/portable communications equipment
could cause interference if it is inadvertently brought into patient areas. For this reason, an additional factor of
10/3 is used in calculating the recommended separation distance for transmitters in these frequency ranges.
c
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land
mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically
with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic
site survey should be considered. If the measured field strength in the location in which the ADSIII Anesthetic
machine is used exceeds the applicable RF compliance level above, the ADSIII Anesthetic machine should
be observed to verify normal operation. If abnormal performance is observed, additional measures may be
necessary, such as reorienting or relocating the ADSIII Anesthetic machine.
d
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 10 V/m.
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User Manual
NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2 The ISM(industrial, scientific and medical) bands between 150kHz and 80MHz are 6.765MHz to
6.795MHz; 13.553 MHz to 14.567 MHz; 26.957 MHz to 27.283 MHz; and 40.66 MHz to 40.70 MHz.
NoTE 3 An additional factor of 10/3 is used in calculating the recommended separation distance for transmitters
in the ISM frequency bands between 150kHz and 80 MHz and in the frequency range 80 MHz to 2.5 GHz to
decrease the likelihood that mobile/portable communications equipment could couse interference if it is
inadvertently brought into patient areas.
NOTE 4 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption
and reflection from structures, objects and people.
10—8
10 Specifications and Operation Theory
CAUTION: The device should be storaged at the room that is drafty and no
corrosion gas exists.
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User Manual
10—10
10.8
Communication Inverter
Power
AC/DC Ampilifer Interface and Power
DC/DC Management
airway/air/gas
pressure
Ins/exp/cmv valve
Anesthetic Ventilator Specifications
Top light
Back light
10—11
10 Specifications and Operation Theory
User Manual
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10 Specifications and Operation Theory
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10 Specifications and Operation Theory
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